510(k) · Cleared
ClearedBSC Sonicath Ultra Intravascular Ultrasound Imaging Wire with Detachable Adapter & BSC Sonicath Ultra Ultrasound Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 9, 1998 as substantially equivalent to K970049 (Cardiovascular Imaging Systems, Inc., 1997) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 9, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942927 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK942927 0.035 in. Wise WireBoston Scientific Corp · 1995
- This deviceK982840 BSC Sonicath Ultra Intravascular Ultrasound Imaging Wire with…Boston Scientific Corp · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942927 | 0.035 in. Wise Wire | Boston Scientific Corp | 1995 | — |
| 0 (this device) | K982840 | BSC Sonicath Ultra Intravascular Ultrasound Imaging Wire with Detachable… | Boston Scientific Corp | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ (37410/456221 & BSC, Sonicath Ultra…Summary page 1…ystem (21 C.F.R. § 892.1560) Diagnostic Ultrasonic Transducer (21 C.F.R. § 892.1570) Predicate Devices 1. BSC Sonicath Ultra Intravascular Ultrasound Imaging Catheter (K970049) 2. BSC WiseWire Intravascular Ultrasound Imaging Core Wire (K942927) BSC Confidential 66" G667 Intravascular Ul… | 1997 |
| * | K942927 | 0.035 in. Wise WireSummary page 1….R. § 892.1570) Predicate Devices 1. BSC Sonicath Ultra Intravascular Ultrasound Imaging Catheter (K970049) 2. BSC WiseWire Intravascular Ultrasound Imaging Core Wire (K942927) BSC Confidential 66" G667 Intravascular Ultrasound Imaging Wire 510(k)Notification Intended Use/Indications T… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K970049.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The BSC Imaging Wire is intended to be used for the ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
The Imaging Wire is specifically indicated for use with diagnostic or interventional devices which are compatible with 0.035” guidewires.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982840: BSC Sonicath Ultra Intravascular Ultrasound Imaging Wire with Detachable Adapter & BSC Sonicath Ultra Ultrasound Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982840
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026